510(k) · Cleared
Recalled · 2003Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Western Ent. · NFB Conserver, Oxygen
Cleared on May 16, 2001 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- May 16, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- NFB
- Recalls
- 3
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK010747 Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609…Western Ent. · 2001
- Descendant · cites it directly · 4 of its ownK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK020475 Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK070740 Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK250322 Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031983Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003 · cites it directly4descendants
- K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002 · cites it directly3descendants
- K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007 · 2 generations on1descendant
- K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006 · 2 generations on1descendant
- K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612… | Western Ent. | 2001 | — |
| +1 | K031983 | Inovo, Inc, Economizer Conserving Regulator | Inovo, Inc. | 2003 | — |
| +1 | K020475 | Chad Therapeutics Oxypenumatic Cypress Model 511 | Chad Therapeutics, Inc. | 2002 | — |
| +2 | K070740 | Chad Therapeutics Bonsai Model 800 | Chad Therapeutics, Inc. | 2007 | — |
| +2 | K061785 | Cyl-Fil Oxygen System | Responsive Respiratory, Inc. | 2006 | — |
| +3 | K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFB device
- #1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2003 | Not classified | Z-0054-04 | Other | The demand valve is defective and does not function as intended in the 'Conservative Mode'. |
| Oct 2, 2003 | Not classified | Z-0055-04 | Other | The demand valve is defective and does not function as intended in the 'Conservative Mode'. |
| Oct 2, 2003 | Not classified | Z-0056-04 | Other | The demand valve is defective and does not function as intended in the 'Conservative Mode'. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031983 (Inovo, Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFB
Too few NFB 510(k)s in any year since 2007 to give a median.
Recalls per year · NFB
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFB
8in 2025
MAUDE reports naming product code NFB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010747: Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010747
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026